Competitive Accuracy of Radiological Imaging Compared to Liver Biopsy in Patients With Liver Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Ultrasound elastography comparison to histological examination of liver biopsy specimen
研究概览
简要总结
The study "Competitive Accuracy of Radiological Imaging Compared to Liver Biopsy in Patients With Liver Fibrosis" is designed to test the accuracy of non-interventional radiological imaging and compare its results with the "gold standard" liver biopsy. This is prospective non-randomized single patient group study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic liver disease
- •signed informed consent
- •liver biopsy indicated by treating gastroenterologist/infectologist
排除标准
- •non-corrected blood coagulation tests
- •acute liver disease
- •age below 18 years or above 80 years
- •disagreement to participate in the study
- •pregnancy
结局指标
主要结局
Ultrasound elastography comparison to histological examination of liver biopsy specimen
时间窗: Baseline only
Liver stiffness measured by ultrasound elastography (2D-SWE) in kPa is compared to histological examination of liver biopsy specimen at a single time point before initiating antiviral treatment.
Dynamic liver scintigraphy with 99mTc-mebrofenin comparison to histological examination of liver biopsy specimen I
时间窗: Baseline only
Dynamic liver scintigraphy with 99mTc-mebrofenin parameter liver clearance (%/min/m2) is compared to histological examination of liver biopsy specimen at a single time point before initiating antiviral treatment.
Dynamic liver scintigraphy with 99mTc-mebrofenin comparison to histological examination of liver biopsy specimen II
时间窗: Baseline only
Dynamic liver scintigraphy with 99mTc-mebrofenin parameter uptake time (min.) is compared to histological examination of liver biopsy specimen at a single time point before initiating antiviral treatment.
Dynamic liver scintigraphy with 99mTc-mebrofenin comparison to histological examination of liver biopsy specimen III
时间窗: Baseline only
Dynamic liver scintigraphy with 99mTc-mebrofenin parameter liver excretion (30 min./peak ratio) is compared to histological examination of liver biopsy specimen at a single time point before initiating antiviral treatment.
次要结局
- Comparison of radiological imaging tests between each other III(Baseline only)
- Comparison of radiological imaging tests between each other I(Baseline only)
- Comparison of radiological imaging tests between each other II(Baseline only)